Final Report of The National Academies Human Embryonic Stem Cell Research Advisory Committee and 2010 Amendments to the National Academies Guidelines for Human Embryonic Stem Cell Research (2010)

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This letter report updates the National Academies' Guidelines for Human Embryonic Stem Cell Research, taking into account the expanded role of the National Institutes of Health in overseeing human embryonic stem cell research, and identifying the future role of the National Academies in stem cell research oversight.

Originally published in 2005, the National Academies' Guidelines for Human Embryonic Stem Cell Research laid out standards for responsible and ethical conduct in a controversial field of research that largely lacked federal funding or oversight. Updates in 2007 and 2008 reflected changes in the science of stem cell research.

This final report from the National Academies Human Embryonic Stem Cell Research Advisory Committee and 2010 update of the National Academies' Guidelines recognizes recent shifts in federal policies on stem cell research. In March 2009, previous policy restricting federal funding for human embryonic stem cell research was rescinded, and the National Institutes of Health were asked to develop new guidance on stem cell research.

The letter report's authoring committee finds that where there is complete overlap, the National Institutes of Health's guidelines should supersede their own; however, the National Academies' Guidelines can continue to help guide research, particularly in areas that are outside the bounds of federal government funding.

Key Messages

A forum to bring together key stakeholders, including federal, state, academic, patient and industry organizations and institutions for periodic meetings to address topics of shared interest and concern to the broader stem cell research, regenerative medicine, and policy communities, is needed.

In the future, it is likely that the uses of stem cells, as opposed to the derivation of new lines, are likely to provide a larger share of any controversy or concern surrounding stem cell research.

Non-NIH guidelines will continue to be a significant source of guidance for human embryonic stem cell research in three areas overall: the derivation of human embryonic stem cells, which cannot be supported by federal funds and therefore require oversight outside the NIH guidelines; research on human embryonic stem cells produced from sources ineligible for NIH funding, which are therefore not subject to the NIH guidelines; and limits on the research uses of embryonic stem cells, which are only briefly addressed in the NIH guidelines.

The continued use of embryonic stem cell research oversight (ESCRO) committees is useful, especially in circumstances where new human embryonic stem cells are being derived.

To avoid complications, contradictions, and confusion, the letter report's authoring committee has developed an updated version of the National Academies’ Guidelines that acknowledges the issuance of the NIH guidelines and incorporates references to the NIH guidelines as appropriate.

When there is complete overlap, the report's authoring committee recommends that the NIH guidelines supersede its own.

Where there are gaps or limitations in the NIH guidelines, the report's authoring committee recommends continued adherence to the National Academies' Guidelines